NCT01796535Unknown不适用
An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Fusion
研究概览
简要总结
This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.
详细描述
For all patients participating in the registry, the following outcomes will be analyzed:
- Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
- Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
- Change in Oswestry Disability Index (ODI) score from baseline
- Proportion of patients with a device related complication
- Proportion of patients with lack of revision, removal, or reoperation
- Proportion of patients with radiographic fusion
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient understands the nature of the procedure and provides written informed consent
- •Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
- •Age > 18 years
- •Patient is treated with the Optiport™ and Opticage™ products
排除标准
- 未提供
结局指标
主要结局
Fusion
时间窗: 1 year
Image Assessment
次要结局
未报告次要终点
研究者
研究点 (2)
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